FDA.reportPublic FDA data

SWL ULTRA ADVANTAGE

Manufacturer
ELTTAC Inc DBA SWL | King Bio, INC
Effective date
2016-05-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:07:51

Label at a glance#

ProductSWL ULTRA ADVANTAGE
Active ingredientARTEMISIA ABROTANUM FLOWERING TOP, SEMECARPUS ANACARDIUM JUICE, BARIUM CARBONATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, CINCHONA OFFICINALIS BARK, FUCUS VESICULOSUS, SUS SCROFA ADRENAL GLAND, GRAPHITE, HELLEBORUS NIGER ROOT, PORK LIVER, BOS TAURUS HYPOTHALAMUS, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, NIACINAMIDE, SUS SCROFA PANCREAS, SOLIDAGO VIRGAUREA FLOWERING TOP, THYMOL, THYMUS SERPYLLUM, THYROID, UNSPECIFIED
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Abrotanum 8X, Anacardium orientale 8X, Baryta carbonica 8X, Calcarea carbonica 8X, Calcarea phosphorica 8X, Cinchona officinalis 8X, 32C, Fucus vesiculosus 8X, Glandula suprarenalis suis 8X, 12X, 16X, Graphites 8X, 32C, Helleborus niger 8X, Hepar suis 8X, 12X, 16X, Hypothalamus 8X, Lycopodium clavatum 8X, Magnesia phosphorica 8X, Nicotinamidum 8X, 32C, Pancreas suis 8X, 12X, 16X Solidago virgaurea 12X, Thymolum 8X, Thymus serpyllum 8X, Thyroidinum 8X.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Alcohol (15 % v/v), glycerin (10 % v/v), purified water

INDICATIONS & USAGE SECTION

Indications: For temporary relief of symptoms related to excess appetite, stress, cravings, regulation of fat metabolism, emotional eating & detoxification.

WARNINGS SECTION

Warnings: Stop use and ask your doctor if symptoms persist or worsen. If pregnant or breast-feeding, take only on advice of a healthcare professional. Keep out of reach of children. Contains alcohol. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions: Shake bottle vigorously 10 times prior to use. Apply three sprays under the tongue twice daily, upon awakening and before sleeping. Do not eat, drink, or brush your teeth within 5-10 minutes before or after taking this product. Consult a physician prior to use in children under 12 years of age.

OTC - PURPOSE SECTION

Indications: For temporary relief of symptoms related to:

  • excess appetite
  • stress, cravings
  • regulation of fat metabolism
  • emotional eating
  • detoxification

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69727-0001-12020-01-31C16284748780-19d75b9d0-1f72-f424-e053-dadaa90a57ceSWL ULTRA ADVANTAGE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69727-0001-1SWL ULTRA ADVANTAGE30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69727-0001SWL ULTRA ADVANTAGE (ABROTANUM, ANACARDIUM ORIENTALE, BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CINCHONA OFFICINALIS, FUCUS VESICULOSUS, GLANDULA SUPRARENALIS SUIS, GRAPHITES, HELLEBORUS NIGER, HEPAR SUIS, HYPOTHALAMUS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, NICOTINAMIDUM, PANCREAS SUIS, SOLIDAGO VIRGAUREA, THYMOLUM, THYMUS SERPYLLUM, THYROIDINUM) LIQUID [ELTTAC INC DBA SWL]2Legacy NDC, 1 package rows20160504_5847ba5d-bb2c-4d5d-9497-3fbc1f2593f7.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69727-000169727-0001-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARTEMISIA ABROTANUM FLOWERING TOPQG07G580U0ACTIB
SEMECARPUS ANACARDIUM JUICEY0F0BU8RDUACTIB
BARIUM CARBONATE6P669D8HQ8ACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
CINCHONA OFFICINALIS BARKS003A158SBACTIB
FUCUS VESICULOSUS535G2ABX9MACTIB
SUS SCROFA ADRENAL GLAND398IYQ16YVACTIB
GRAPHITE4QQN74LH4OACTIB
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
PORK LIVER6EC706HI7FACTIB
BOS TAURUS HYPOTHALAMUSS6G2NLH4Y7ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
NIACINAMIDE25X51I8RD4ACTIB
SUS SCROFA PANCREAS9Y3J3362RYACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
THYMOL3J50XA376EACTIB
THYMUS SERPYLLUM86H4S6K51NACTIB
THYROID, UNSPECIFIED0B4FDL9I6PACTIB
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8651504a-fb7d-43ab-8d95-bf04badcbb3f5847ba5d-bb2c-4d5d-9497-3fbc1f2593f72016-05-03WarningsExact identifier
spl id: 8651504a-fb7d-43ab-8d95-bf04badcbb3f
spl set id: 5847ba5d-bb2c-4d5d-9497-3fbc1f2593f7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.